Kaposi Sarcoma, Sarcoma, Kaposi
Conditions
Keywords
Human Herpesvirus-8/HHV8, Immune Modulation, CC-4047, IMiD, Kaposi Sarcoma
Brief summary
Background: \- Pomalidomide is a drug that can treat cancer through several mechanisms. It is taken by mouth (orally). Pomalidomide can help treat cancer by blocking certain factors that promote tumor growth or by stimulating the immune system to attack tumor cells. It also prevents the growth of new blood vessels that help cancer grow. Researchers want to see if pomalidomide can treat Kaposi sarcoma, a rare and potentially fatal skin cancer. Because Kaposi sarcoma may be associated with human immunodeficiency virus (HIV) infection, researchers want to test the drug in people with and without HIV infection. Objectives: \- To see if pomalidomide is a safe and effective treatment for Kaposi sarcoma in people with or without HIV. Eligibility: * Individuals at least 18 years of age who have Kaposi sarcoma. * Participants may or may not have HIV infection. Design: * Potential participants will be screened with a medical history and physical exam. Blood and saliva samples will be taken and a chest X-ray will be performed. A skin biopsy of a Kaposi sarcoma lesion may be performed if one has not already been done. Other imaging studies may be performed if needed. * Participants will take pomalidomide capsules every day for 3 weeks, followed by a 1-week break. These 28 days are one cycle of treatment. * Participants will have up six cycles of treatment, unless the lesions completely resolve sooner. If there are signs of improvement after six cycles but the lesions are not completely gone, up to another six cycles of treatment may be given. * Treatment will be monitored with frequent blood tests and other studies including photograph and other imaging of skin lesions. * Participants will have regular follow-up visits for 5 years after stopping treatment....
Detailed description
Background: Kaposi Sarcoma (KS) is an incurable, multicentric angioproliferative tumor that most frequently involves the skin. It is seen most frequently in people with human immunodeficiency virus (HIV) or other forms of immune compromise. Current therapies are limited by toxicities, including cumulative cardiotoxicity, while effective oral agents, agents deliverable in resource-limited settings, and agents deliverable long-term for relapsing disease are all lacking. Objective: The primary objective of this study is to: Assess the safety, tolerability and pharmacokinetics of pomalidomide in subjects with Kaposi sarcoma, whether HIV associated or not. Eligibility: * Age greater than or equal to 18 years * Measurable, pathologically confirmed KS * Any HIV status; HIV-associated KS subjects must be receiving and able to comply with highly active antiretroviral therapy (HAART) and have achieved an HIV viral load \<10,000 copies/mL * Hematologic and biochemical parameters within prespecified limits at baseline * Willing to use effective birth control, as defined in the full protocol * For subjects enrolled in the anti-tumor activity assessment phase, if KS is HIV-associated it must be increasing despite HAART and HIV suppression for greater than or equal to 2 months, or stable despite HAART for greater than or equal to 3 months * No symptomatic pulmonary or visceral KS * No specific KS therapy within 4 weeks (6 weeks if that therapy was bevacizumab) * Neither pregnant nor breast feeding Design: This is an open label single agent phase I/II study of pomalidomide in patients with KS. In the phase I portion, up to six subjects will initially be treated with pomalidomide 5mg daily for 21 days of a 28 day cycle. Subject to toxicity evaluation, this dosage may be deescalated to 3mg daily for 21 days of a 28 day cycle in a second cohort of up to six subjects. If either dose proves tolerable, the study will proceed to the phase II portion, and additional subjects to a goal of 15 HIV positive and 10 HIV negative subjects evaluable for response will be added at the highest tolerable dose to gain preliminary information on activity.
Interventions
DRUGPomalidomide
5 mg by mouth (p.o.) for 21 of 28 days
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* INCLUSION CRITERIA: * Age greater than or equal to 18 Years. * Any human immunodeficiency virus (HIV) status. * Kaposi sarcoma pathologically confirmed by Department of Pathology, Clinical Center, National Institutes of Health. * At least five measurable Kaposi sarcoma (KS) lesions with no previous local radiation, surgical or intralesional cytotoxic therapy that would prevent response assessment for that lesion. * Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2 * Life expectancy greater than or equal to 6 months * For patients with HIV-associated KS: * Must be receiving, and adherent to, a highly active antiretroviral therapy (HAART) regimen consistent with current clinical guidelines. * Must have been receiving HAART for at least one month. * Must have achieved an HIV viral load (VL) \<10,000 copies/mL. * The following hematological parameters: * Hemoglobin greater than or equal to 10 g/dL * Platelets greater than or equal to 75,000 cells/mm(3) * Absolute neutrophil count (ANC) greater than or equal to 1000 cells/mm(3) * The following biochemical parameters: * Estimated or measured creatinine clearance greater than or equal to 45mL/minute * Serum alanine aminotransferase (ALT) less than or equal to 2.5 times upper limit of normal * Serum aspartate aminotransferase (AST) less than or equal to 2.5 times upper limit of normal * Bilirubin less than or equal to 1.5 times upper limit of normal unless the patient is receiving protease inhibitor therapy (e.g., indinavir, ritonavir, nelfinavir, or atazanavir) known to be associated with increased bilirubin, in which case total bilirubin less than or equal to 7.5 mg/dL with direct fraction less than or equal to 0.7 mg/dL. * Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 14 days prior to and again within 24 hours before starting pomalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking pomalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy. All subjects must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods, and also * All study participants must agree to be registered into the mandatory POMALYST Risk Evaluation and Mitigation Strategy (REMS) program and be willing and able to comply with the requirements of the POMALYST REMS program. * Females of reproductive potential must be willing to adhere to the scheduled pregnancy testing as required in the POMALYST REMS program. * Able to take aspirin 81mg daily or if intolerant of aspirin, able to take a substitute thromboprophylaxis such as low molecular weight heparin at a thromboprophylactic dose (such as enoxaparin 0.5mg/kg once daily). * Willing and able to give informed consent. * For subjects with HIV-associated entered after a tolerable dose has been determined, KS lesions must be either: * Increasing despite HAART and HIV suppression below the limit of detection (48 copies/mL) in the two months prior to screening or * Stable despite HAART for at least three months. Stable disease must be symptomatic (examples of symptomatic disease include disease associated with pain, edema, psychological distress and/or social withdrawal). This is to gain preliminary information about pomalidomide activity without confounding due to HAART initiation.
Exclusion criteria
* Symptomatic pulmonary KS. * Symptomatic visceral KS (except for non-ulcerating disease restricted to the oral cavity). * Specific KS therapy, including cytotoxic chemotherapy but not including HAART, within the past 4 weeks (6 weeks if the therapy was bevacizumab). * Use of other anticancer treatments or agents within the past 4 weeks (6 weeks if the therapy was a monoclonal antibody). * History of malignant tumors other than KS, unless: * In complete remission for greater than or equal to 1 year from the time response was first documented or * Completely resected basal cell carcinoma or * In situ squamous cell carcinoma of the cervix or anus. * History of infection meeting any of the following criteria: * Any infection that would be scored as grade 4 by Common Terminology Criteria for Adverse Events (CTCAE) that occurred within six weeks of study screening. * Any infection that would be scored as grade 3 by CTCAE that occurred within two weeks of study screening. * History of fungal and mycobacterial infections, unless at least six weeks has passed since the completion of induction antimicrobial therapy. Patients may be receiving consolidation therapy for infections of these types. * Any abnormality that would be scored as a greater than or equal to grade 3 toxicity by CTCAE, except: * Obesity is not considered an abnormality for the purposes of eligibility assessment unless in the opinion of the Principal Investigator or Lead Associate Investigator its clinical consequences in a particular subject places the subject at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the study. * Lymphopenia * Asymptomatic hyperuricemia, hypophosphatemia, or creatine kinase (CK) Elevations * Direct manifestations of KS * Direct manifestations of HIV infection, except for neurologic or cardiac manifestations * Direct manifestations of HIV therapy, except for neurologic or cardiac manifestations. * History of venous or arterial thromboembolism, unless: * Line-related thrombosis without embolus occurring greater than or equal to 1 year prior to screening. Complications resulting from atherosclerotic coronary artery disease, peripheral vascular disease, or cerebrovascular disease (including infarction) are not considered
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve Extrapolated to Infinity (AUCinf) | At pre-dose, 1, 2, 3, 4, 6, and 8 hours after dose on Cycle 1 Day 1, and pre-dose, 1, 2, 3, 4, 6, 8, and 24 hours after dose on Cycle 1 Day 15. | AUC is a measure of the serum concentration of Pomalidomide over time. It is used to characterize drug absorption. The AUC extrapolated to infinity was used, unless the percent extrapolated exceeded 25% in which case AUC to the last quantifiable time point (AUCLast) was used. The steady-state exposure on Day 15 of cycle 1 was calculated using AUCLast. |
| Half-Life of Pomalidomide | At pre-dose, 1, 2, 3, 4, 6, and 8 hours after dose on Cycle 1 Day 1, and pre-dose, 1, 2, 3, 4, 6, 8, and 24 hours after dose on Cycle 1 Day 15. | Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half. |
| Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | During each cycle and 4 weeks after completing therapy, with any continuing AE's observed until resolution, approximately 124 months and 1 day. | Adverse events (AE's) that are possibly, probably, and/or definitely attributed to pomalidomide were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. |
| Progression Free Survival (PFS) | time from day 1 of pomalidomide therapy until progression requiring a change in therapy, an average of 9.97 months | PFS is defined as time from day 1 of pomalidomide therapy until progression requiring a change in therapy, estimated using the Kaplan-Meier method. Progression was assessed using the Modified Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Group criteria. Progressive disease (PD) involved a 25% or greater increase in total lesions, nodular lesion, or area of the five indicator lesions. |
| Maximal Plasma Concentration (Cmax) of Pomalidomide | At pre-dose, 1, 2, 3, 4, 6, and 8 hours after dose on Cycle 1 Day 1, and pre-dose, 1, 2, 3, 4, 6, 8, and 24 hours after dose on Cycle 1 Day 15. | Plasma concentrations of pomalidomide were assayed using high-performance liquid chromatography with fluorescence detection with a lower limit of quantitation of 1 ng/mL and were recorded as observed values. A non-compartmental analysis was used to calculate plasma pharmacokinetic parameters (Pharsight, Mountain View, California). |
| Time to Maximum Observed Serum Concentration of Pomalidomide (Cmax) | At pre-dose, 1, 2, 3, 4, 6, and 8 hours after dose on Cycle 1 Day 1, and pre-dose, 1, 2, 3, 4, 6, 8, and 24 hours after dose on Cycle 1 Day 15. | Time to maximum observed serum concentration of Pomalidomide was reported. |
| Area Under the Plasma Concentration Versus Time Curve (AUC) to the Last Timepoint (AUCLast) | At pre-dose, 1, 2, 3, 4, 6, and 8 hours after dose on Cycle 1 Day 1, and pre-dose, 1, 2, 3, 4, 6, 8, and 24 hours after dose on Cycle 1 Day 15. | Area under the plasma concentration versus time curve (AUC) was calculated using the log-linear trapezoidal method. The AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change Between Timepoints Baseline to 4 Weeks, Baseline to 8 Weeks, and Baseline to End of Treatment in Kaposi Sarcoma-Associated Herpesvirus (KSHV) Viral Load | Baseline to 4 weeks, baseline to 8 weeks and baseline to end of treatment | KSHV viral load in peripheral blood mononuclear cells was assessed by modifying a sandwich enzyme-linked immunosorbent assay (ELISA). Viral load testing may provide useful information on the occurrence of KSHV replication. Undetectable levels is good. |
| Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Baseline, timepoint 1: after 3 months of therapy, and timepoint 2: 1 month after completion of therapy | The percentage of participants responding to each question with the indicated responses is shown. Changes in quality of life in participants receiving pomalidomide. HRQL was analyzed using a mixed-model repeated-measures analysis and the marginal homogeneity test for Kaposi sarcoma-specific questions. Three supplemental questions addressing pain, swelling, and satisfaction with physical appearance was used to collect quality of life data. |
| Human Immunodeficiency Virus (HIV) Viral Load | Baseline to 4 weeks, baseline to 8 weeks and baseline to end of treatment | HIV viral load in peripheral blood mononuclear cells was assessed by quantitative real-time polymerase chain reaction (PCR). The lower limit of detection for HIV viral load is \<50 copies mL. |
| Antitumor Effect of a Second Course of Pomalidomide | After completion of 2 cycles of therapy up to 48 weeks after the start of the second course of Pomalidomide | Antitumor effect of pomalidomide was assessed at the established tolerated dose after a second course of pomalidomide. Kaposi sarcoma responses were assessed using the Modified Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Group criteria. Complete Response (CR) required clinical resolution of all lesions and tumor-associated phenomenon with biopsy confirmation. Clinical Complete Response (cCR) is resolution of all lesions except for some residual pigmentation but who did not have a biopsy of a representative pigmented area. Partial Response (PR) required ≥ 50% decrease in the number of lesions and/or sum product of the diameters of marker lesions and/or nodularity of lesions, and no new lesions in previously uninvolved areas or criteria. Stable Disease (SD) was assessed for all participants who did not meet criteria doe CR, PR, or PD. And progressive disease (PD) involved a 25% or greater increase in total lesions, nodular lesion, or area of the five indicator lesions. |
| Antitumor Effect of a First Course of Pomalidomide | After completion of 2 cycles of therapy up to 48 weeks | Antitumor effect of pomalidomide was assessed at the established tolerated dose after a first course of pomalidomide. Kaposi sarcoma responses were assessed using the Modified Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Group criteria. Complete Response (CR) required clinical resolution of all lesions and tumor-associated phenomenon with biopsy confirmation. Clinical Complete Response (cCR) is resolution of all lesions except for some residual pigmentation but who did not have a biopsy of a representative pigmented area. Partial Response (PR) required ≥ 50% decrease in the number of lesions and/or sum product of the diameters of marker lesions and/or nodularity of lesions, and no new lesions in previously uninvolved areas or criteria. Stable Disease (SD) was assessed for all participants who did not meet criteria doe CR, PR, or PD. And progressive disease (PD) involved a 25% or greater increase in total lesions, nodular lesion, or area of the five indicator lesions. |
| Self-Reported Health-Related Quality of Life (HRQL) Instrument: Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) | Baseline, after 3 months of therapy, and after completion of therapy, up to 48 weeks | Changes in quality of life in participants receiving pomalidomide. HRQL was analyzed using a mixed-model repeated-measures analysis for FAHI and the marginal homogeneity test for Kaposi sarcoma-specific questions such as physical well-being (PWB), emotional well-being (EWB), functional and global well-being (FGWB), social well-being (SWB), and cognitive functioning (CF). The range of possible scores for each subscale was as follows: PWB and EWB, 0 to 40; FGWB, 0 to 52; SWB, 0 to 32; CF, 0 to 12. The total FAHI score, with possible scores ranging from 0 to 176, was calculated as the sum of all five subscale values, with higher scores indicating better results. Questionnaires completed at early withdrawal visits were not included in the analyses. |
| Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Baseline, timepoint 1: after 3 months of therapy, and timepoint 2: 1 month after completion of therapy | The number of participants responding to each question with the indicated responses is shown. Changes in quality of life in participants receiving pomalidomide. HRQL was analyzed using a mixed-model repeated-measures analysis and the marginal homogeneity test for Kaposi sarcoma-specific questions. Three supplemental questions addressing pain, swelling, and satisfaction with physical appearance was used to collect quality of life data. |
| Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment | Baseline to 4 weeks, baseline to 8 weeks and baseline to end of treatment | Cytokines were evaluated using MSD 96-Well Multiarray Proinflammatory 7-plex assay (MesoScale Discovery). |
| Change in Immune Cytokines Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8) and Cluster of Differentiation 19 (CD19) Among Participants With and/or Without Human Immunodeficiency Virus (HIV) | Baseline to 4 weeks, baseline to 8 weeks, and baseline to end of treatment | Fluorescence activated cell sorting. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Date treatment consent signed to date off study, approximately 124 months and 1 day. | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
| Number of Dose-limiting Toxicities | First 8 weeks (2 cycles) of drug administration | A dose limiting toxicity is any grade 4 toxicity not including lymphopenia, cluster of differentiation 4 (CD4) lymphopenia, neutropenia, anemia and bilirubin or creatine kinase (CK) elevation that is at least possibly due to pomalidomide and is not attributable to human immunodeficiency virus (HIV), its therapy or Kaposi Sarcoma (KS). Any grade 3 toxicity that is at least possibly due to pomalidomide and is not attributable to HIV, its therapy, or KS and restrictions such as grade 3 thrombocytopenia if grade 3 for 14 days or more, Grade 3 asymptomatic hyperuricemia or hypophosphatemia, or Grade 3 amylase elevations. Any arterial or deep venous thromboembolic event or a second superficial thromboembolic event that is at least possibly due to pomalidomide. Inability to deliver pomalidomide on at least 50% of scheduled days during the first two cycles of therapy as a result of toxicity that is probably or definitely attributable to pomalidomide. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pomalidomide 5mg Daily All participants treated with pomalidomide 5 mg by mouth (p.o.) for 21 of 28 days. | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death during follow up period | 2 |
| Overall Study | Death on study | 1 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Physician Decision | 8 |
Baseline characteristics
| Characteristic | Pomalidomide 5mg Daily |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants |
| Age, Continuous | 52.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Prior Kaposi Sarcoma (KS) Therapy Immunomodulatory therapy | 3 Participants |
| Prior Kaposi Sarcoma (KS) Therapy Interferon alpha | 5 Participants |
| Prior Kaposi Sarcoma (KS) Therapy Liposomal doxorubicin | 14 Participants |
| Prior Kaposi Sarcoma (KS) Therapy Local therapy | 10 Participants |
| Prior Kaposi Sarcoma (KS) Therapy Paclitaxel | 8 Participants |
| Prior Kaposi Sarcoma (KS) Therapy Prior systemic therapy | 22 Participants |
| Prior Kaposi Sarcoma (KS) Therapy Radiotherapy | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment United States | 28 participants |
| Sex/Gender, Customized Cisgender male | 27 Participants |
| Sex/Gender, Customized Transgender male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 28 |
| other Total, other adverse events | 28 / 28 |
| serious Total, serious adverse events | 12 / 28 |
Outcome results
Primary
Area Under the Curve Extrapolated to Infinity (AUCinf)
AUC is a measure of the serum concentration of Pomalidomide over time. It is used to characterize drug absorption. The AUC extrapolated to infinity was used, unless the percent extrapolated exceeded 25% in which case AUC to the last quantifiable time point (AUCLast) was used. The steady-state exposure on Day 15 of cycle 1 was calculated using AUCLast.
Time frame: At pre-dose, 1, 2, 3, 4, 6, and 8 hours after dose on Cycle 1 Day 1, and pre-dose, 1, 2, 3, 4, 6, 8, and 24 hours after dose on Cycle 1 Day 15.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Grade 1 | Area Under the Curve Extrapolated to Infinity (AUCinf) | Cycle 1 Day 1 | 567.3 hours*ng/ml | Standard Deviation 423.2 |
| Grade 1 | Area Under the Curve Extrapolated to Infinity (AUCinf) | Cycle 1 Day 15 | 805.3 hours*ng/ml | Standard Deviation 986.9 |
Primary
Area Under the Plasma Concentration Versus Time Curve (AUC) to the Last Timepoint (AUCLast)
Area under the plasma concentration versus time curve (AUC) was calculated using the log-linear trapezoidal method. The AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Time frame: At pre-dose, 1, 2, 3, 4, 6, and 8 hours after dose on Cycle 1 Day 1, and pre-dose, 1, 2, 3, 4, 6, 8, and 24 hours after dose on Cycle 1 Day 15.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Grade 1 | Area Under the Plasma Concentration Versus Time Curve (AUC) to the Last Timepoint (AUCLast) | Cycle 1 Day 1 | 466.5 hours*ng/mL | Standard Deviation 304 |
| Grade 1 | Area Under the Plasma Concentration Versus Time Curve (AUC) to the Last Timepoint (AUCLast) | Cycle 1 Day 15 | 504.5 hours*ng/mL | Standard Deviation 325.9 |
Primary
Half-Life of Pomalidomide
Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half.
Time frame: At pre-dose, 1, 2, 3, 4, 6, and 8 hours after dose on Cycle 1 Day 1, and pre-dose, 1, 2, 3, 4, 6, 8, and 24 hours after dose on Cycle 1 Day 15.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Grade 1 | Half-Life of Pomalidomide | Cycle 1 Day 1 | 6.85 hours | Standard Deviation 2.13 |
| Grade 1 | Half-Life of Pomalidomide | Cycle 1 Day 15 | 8.27 hours | Standard Deviation 6.61 |
Primary
Maximal Plasma Concentration (Cmax) of Pomalidomide
Plasma concentrations of pomalidomide were assayed using high-performance liquid chromatography with fluorescence detection with a lower limit of quantitation of 1 ng/mL and were recorded as observed values. A non-compartmental analysis was used to calculate plasma pharmacokinetic parameters (Pharsight, Mountain View, California).
Time frame: At pre-dose, 1, 2, 3, 4, 6, and 8 hours after dose on Cycle 1 Day 1, and pre-dose, 1, 2, 3, 4, 6, 8, and 24 hours after dose on Cycle 1 Day 15.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Grade 1 | Maximal Plasma Concentration (Cmax) of Pomalidomide | Cycle 1 Day 1 | 53.1 ng/mL | Standard Deviation 27 |
| Grade 1 | Maximal Plasma Concentration (Cmax) of Pomalidomide | Cycle 1 Day 15 | 59.0 ng/mL | Standard Deviation 29.6 |
Primary
Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide
Adverse events (AE's) that are possibly, probably, and/or definitely attributed to pomalidomide were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening.
Time frame: During each cycle and 4 weeks after completing therapy, with any continuing AE's observed until resolution, approximately 124 months and 1 day.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Grade 1 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Low white cell count | 21 Participants |
| Grade 1 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Anemia | 16 Participants |
| Grade 1 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Hypothyroidism | 3 Participants |
| Grade 1 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Fatigue | 17 Participants |
| Grade 1 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Febrile neutropenia | 0 Participants |
| Grade 1 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Thrombocytopenia | 16 Participants |
| Grade 1 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Rash | 18 Participants |
| Grade 1 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Nausea | 10 Participants |
| Grade 1 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Lymphocytopenia | 13 Participants |
| Grade 1 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Depression | 1 Participants |
| Grade 1 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Neutropenia | 24 Participants |
| Grade 1 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Impaired concentration | 3 Participants |
| Grade 1 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Vasculitis | 0 Participants |
| Grade 1 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Elevated alanine aminotransferase (ALT) | 7 Participants |
| Grade 1 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Constipation | 18 Participants |
| Grade 1 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Infection | 0 Participants |
| Grade 2 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Hypothyroidism | 3 Participants |
| Grade 2 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Depression | 1 Participants |
| Grade 2 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Rash | 6 Participants |
| Grade 2 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Lymphocytopenia | 2 Participants |
| Grade 2 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Vasculitis | 0 Participants |
| Grade 2 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Anemia | 4 Participants |
| Grade 2 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Thrombocytopenia | 0 Participants |
| Grade 2 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Febrile neutropenia | 0 Participants |
| Grade 2 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Fatigue | 2 Participants |
| Grade 2 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Infection | 7 Participants |
| Grade 2 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Low white cell count | 10 Participants |
| Grade 2 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Constipation | 3 Participants |
| Grade 2 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Nausea | 0 Participants |
| Grade 2 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Elevated alanine aminotransferase (ALT) | 0 Participants |
| Grade 2 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Neutropenia | 26 Participants |
| Grade 2 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Impaired concentration | 1 Participants |
| Grade 3 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Depression | 0 Participants |
| Grade 3 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Vasculitis | 1 Participants |
| Grade 3 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Elevated alanine aminotransferase (ALT) | 0 Participants |
| Grade 3 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Constipation | 0 Participants |
| Grade 3 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Rash | 1 Participants |
| Grade 3 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Hypothyroidism | 0 Participants |
| Grade 3 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Impaired concentration | 0 Participants |
| Grade 3 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Thrombocytopenia | 0 Participants |
| Grade 3 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Nausea | 0 Participants |
| Grade 3 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Anemia | 0 Participants |
| Grade 3 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Neutropenia | 14 Participants |
| Grade 3 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Fatigue | 0 Participants |
| Grade 3 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Febrile neutropenia | 1 Participants |
| Grade 3 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Lymphocytopenia | 0 Participants |
| Grade 3 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Low white cell count | 1 Participants |
| Grade 3 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Infection | 1 Participants |
| Grade 4 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Nausea | 0 Participants |
| Grade 4 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Low white cell count | 0 Participants |
| Grade 4 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Febrile neutropenia | 0 Participants |
| Grade 4 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Neutropenia | 3 Participants |
| Grade 4 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Lymphocytopenia | 0 Participants |
| Grade 4 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Anemia | 0 Participants |
| Grade 4 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Thrombocytopenia | 0 Participants |
| Grade 4 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Fatigue | 0 Participants |
| Grade 4 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Infection | 0 Participants |
| Grade 4 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Constipation | 0 Participants |
| Grade 4 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Elevated alanine aminotransferase (ALT) | 0 Participants |
| Grade 4 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Impaired concentration | 0 Participants |
| Grade 4 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Depression | 0 Participants |
| Grade 4 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Hypothyroidism | 0 Participants |
| Grade 4 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Rash | 0 Participants |
| Grade 4 | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Vasculitis | 0 Participants |
Primary
Progression Free Survival (PFS)
PFS is defined as time from day 1 of pomalidomide therapy until progression requiring a change in therapy, estimated using the Kaplan-Meier method. Progression was assessed using the Modified Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Group criteria. Progressive disease (PD) involved a 25% or greater increase in total lesions, nodular lesion, or area of the five indicator lesions.
Time frame: time from day 1 of pomalidomide therapy until progression requiring a change in therapy, an average of 9.97 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Grade 1 | Progression Free Survival (PFS) | 10.2 months |
| Grade 2 | Progression Free Survival (PFS) | 10.3 months |
| Grade 3 | Progression Free Survival (PFS) | 9.4 months |
p-value: 0.43Log Rank
Primary
Time to Maximum Observed Serum Concentration of Pomalidomide (Cmax)
Time to maximum observed serum concentration of Pomalidomide was reported.
Time frame: At pre-dose, 1, 2, 3, 4, 6, and 8 hours after dose on Cycle 1 Day 1, and pre-dose, 1, 2, 3, 4, 6, 8, and 24 hours after dose on Cycle 1 Day 15.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Grade 1 | Time to Maximum Observed Serum Concentration of Pomalidomide (Cmax) | Cycle 1 Day 1 | 2.00 hours |
| Grade 1 | Time to Maximum Observed Serum Concentration of Pomalidomide (Cmax) | Cycle 1 day 15 | 2.08 hours |
Secondary
Antitumor Effect of a First Course of Pomalidomide
Antitumor effect of pomalidomide was assessed at the established tolerated dose after a first course of pomalidomide. Kaposi sarcoma responses were assessed using the Modified Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Group criteria. Complete Response (CR) required clinical resolution of all lesions and tumor-associated phenomenon with biopsy confirmation. Clinical Complete Response (cCR) is resolution of all lesions except for some residual pigmentation but who did not have a biopsy of a representative pigmented area. Partial Response (PR) required ≥ 50% decrease in the number of lesions and/or sum product of the diameters of marker lesions and/or nodularity of lesions, and no new lesions in previously uninvolved areas or criteria. Stable Disease (SD) was assessed for all participants who did not meet criteria doe CR, PR, or PD. And progressive disease (PD) involved a 25% or greater increase in total lesions, nodular lesion, or area of the five indicator lesions.
Time frame: After completion of 2 cycles of therapy up to 48 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Grade 1 | Antitumor Effect of a First Course of Pomalidomide | Complete Response (CR) | 1 Participants |
| Grade 1 | Antitumor Effect of a First Course of Pomalidomide | Clinical Complete Response (CCR) | 3 Participants |
| Grade 1 | Antitumor Effect of a First Course of Pomalidomide | Partial Response (PR) | 16 Participants |
| Grade 1 | Antitumor Effect of a First Course of Pomalidomide | Stable Disease (SD) | 5 Participants |
| Grade 1 | Antitumor Effect of a First Course of Pomalidomide | Progressive Disease (PD) | 3 Participants |
Secondary
Antitumor Effect of a Second Course of Pomalidomide
Antitumor effect of pomalidomide was assessed at the established tolerated dose after a second course of pomalidomide. Kaposi sarcoma responses were assessed using the Modified Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Group criteria. Complete Response (CR) required clinical resolution of all lesions and tumor-associated phenomenon with biopsy confirmation. Clinical Complete Response (cCR) is resolution of all lesions except for some residual pigmentation but who did not have a biopsy of a representative pigmented area. Partial Response (PR) required ≥ 50% decrease in the number of lesions and/or sum product of the diameters of marker lesions and/or nodularity of lesions, and no new lesions in previously uninvolved areas or criteria. Stable Disease (SD) was assessed for all participants who did not meet criteria doe CR, PR, or PD. And progressive disease (PD) involved a 25% or greater increase in total lesions, nodular lesion, or area of the five indicator lesions.
Time frame: After completion of 2 cycles of therapy up to 48 weeks after the start of the second course of Pomalidomide
Population: 4/28 participants were eligible for a second course of pomalidomide at time of progression within 12 months of treatment cessation.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Grade 1 | Antitumor Effect of a Second Course of Pomalidomide | Complete Response (CR) | 0 Participants |
| Grade 1 | Antitumor Effect of a Second Course of Pomalidomide | Clinical Complete Response (CCR) | 0 Participants |
| Grade 1 | Antitumor Effect of a Second Course of Pomalidomide | Partial Response (PR) | 2 Participants |
| Grade 1 | Antitumor Effect of a Second Course of Pomalidomide | Stable Disease (SD) | 2 Participants |
| Grade 1 | Antitumor Effect of a Second Course of Pomalidomide | Progressive Disease (PD) | 0 Participants |
Secondary
Change Between Timepoints Baseline to 4 Weeks, Baseline to 8 Weeks, and Baseline to End of Treatment in Kaposi Sarcoma-Associated Herpesvirus (KSHV) Viral Load
KSHV viral load in peripheral blood mononuclear cells was assessed by modifying a sandwich enzyme-linked immunosorbent assay (ELISA). Viral load testing may provide useful information on the occurrence of KSHV replication. Undetectable levels is good.
Time frame: Baseline to 4 weeks, baseline to 8 weeks and baseline to end of treatment
Population: PBMC = peripheral mononuclear cells
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Grade 1 | Change Between Timepoints Baseline to 4 Weeks, Baseline to 8 Weeks, and Baseline to End of Treatment in Kaposi Sarcoma-Associated Herpesvirus (KSHV) Viral Load | 0 copies per million PBMC |
| Grade 2 | Change Between Timepoints Baseline to 4 Weeks, Baseline to 8 Weeks, and Baseline to End of Treatment in Kaposi Sarcoma-Associated Herpesvirus (KSHV) Viral Load | 0 copies per million PBMC |
| Grade 3 | Change Between Timepoints Baseline to 4 Weeks, Baseline to 8 Weeks, and Baseline to End of Treatment in Kaposi Sarcoma-Associated Herpesvirus (KSHV) Viral Load | 0 copies per million PBMC |
p-value: 0.13Wilcoxon signed rank test
p-value: 0.65Wilcoxon signed rank test
p-value: 0.32Wilcoxon signed rank test
p-value: 0.06Wilcoxon signed rank test
p-value: 0.007Wilcoxon signed rank test
Secondary
Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment
Cytokines were evaluated using MSD 96-Well Multiarray Proinflammatory 7-plex assay (MesoScale Discovery).
Time frame: Baseline to 4 weeks, baseline to 8 weeks and baseline to end of treatment
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Grade 1 | Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment | Interleukin 8 (IL8) | 71.9 pg/mL |
| Grade 1 | Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment | Interferon (IFN)-inducible protein 10 (IP-10) | 76.5 pg/mL |
| Grade 1 | Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment | Interleukin 12 (IL12) | 0.02 pg/mL |
| Grade 1 | Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment | Interleukin 10 (IL10) | 0.1 pg/mL |
| Grade 1 | Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment | Interferon gamma (ƴ) | -0.3 pg/mL |
| Grade 1 | Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment | Tumor necrosis factor alpha (TNFα) | 0.3 pg/mL |
| Grade 1 | Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment | Interleukin 6 (IL6) | 0.4 pg/mL |
| Grade 1 | Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment | Interleukin 4 (IL4) | 0.07 pg/mL |
| Grade 1 | Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment | Interleukin 13 (IL13) | 0.7 pg/mL |
| Grade 2 | Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment | Interleukin 10 (IL10) | -0.03 pg/mL |
| Grade 2 | Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment | Interferon gamma (ƴ) | -0.4 pg/mL |
| Grade 2 | Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment | Interleukin 4 (IL4) | 0.1 pg/mL |
| Grade 2 | Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment | Interleukin 6 (IL6) | 0.3 pg/mL |
| Grade 2 | Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment | Interleukin 8 (IL8) | 64.8 pg/mL |
| Grade 2 | Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment | Interleukin 12 (IL12) | 0.00 pg/mL |
| Grade 2 | Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment | Interleukin 13 (IL13) | 0.9 pg/mL |
| Grade 2 | Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment | Tumor necrosis factor alpha (TNFα) | 0.5 pg/mL |
| Grade 2 | Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment | Interferon (IFN)-inducible protein 10 (IP-10) | 18.4 pg/mL |
| Grade 3 | Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment | Interleukin 6 (IL6) | 0.6 pg/mL |
| Grade 3 | Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment | Interferon gamma (ƴ) | -2.4 pg/mL |
| Grade 3 | Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment | Interleukin 13 (IL13) | 0.6 pg/mL |
| Grade 3 | Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment | Interleukin 4 (IL4) | 0.06 pg/mL |
| Grade 3 | Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment | Interferon (IFN)-inducible protein 10 (IP-10) | -73.3 pg/mL |
| Grade 3 | Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment | Interleukin 10 (IL10) | -0.05 pg/mL |
| Grade 3 | Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment | Interleukin 8 (IL8) | 47.5 pg/mL |
| Grade 3 | Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment | Tumor necrosis factor alpha (TNFα) | 0.06 pg/mL |
| Grade 3 | Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment | Interleukin 12 (IL12) | 0.03 pg/mL |
p-value: 0.19Wilcoxon signed rank test
p-value: 0.72Wilcoxon signed rank test
p-value: 0.03Wilcoxon signed rank test
p-value: <0.0001Wilcoxon signed rank test
p-value: <0.0001Wilcoxon signed rank test
p-value: <0.0001Wilcoxon signed rank test
p-value: 0.005Wilcoxon signed rank test
p-value: 0.06Wilcoxon signed rank test
p-value: 0.007Wilcoxon signed rank test
p-value: 0.0003Wilcoxon signed rank test
p-value: 0.0002Wilcoxon signed rank test
p-value: 0.01Wilcoxon signed rank test
p-value: 0.03Wilcoxon signed rank test
p-value: 0.91Wilcoxon signed rank test
p-value: 0.64Wilcoxon signed rank test
p-value: 0.7Wilcoxon signed rank test
p-value: 0.59Wilcoxon signed rank test
p-value: 0.26Wilcoxon signed rank test
p-value: 0.0008Wilcoxon signed rank test
p-value: <0.0001Wilcoxon signed rank test
p-value: 0.007Wilcoxon signed rank test
p-value: 0.005Wilcoxon signed rank test
p-value: 0.007Wilcoxon signed rank test
p-value: 0.007Wilcoxon signed rank test
p-value: 0.42Wilcoxon signed rank test
p-value: 0.85Wilcoxon signed rank test
p-value: 0.16Wilcoxon signed rank test
Secondary
Change in Immune Cytokines Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8) and Cluster of Differentiation 19 (CD19) Among Participants With and/or Without Human Immunodeficiency Virus (HIV)
Fluorescence activated cell sorting.
Time frame: Baseline to 4 weeks, baseline to 8 weeks, and baseline to end of treatment
Population: HIV+ participants = 18.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Grade 1 | Change in Immune Cytokines Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8) and Cluster of Differentiation 19 (CD19) Among Participants With and/or Without Human Immunodeficiency Virus (HIV) | CD4+/All participants | 66.5 cells/µL |
| Grade 1 | Change in Immune Cytokines Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8) and Cluster of Differentiation 19 (CD19) Among Participants With and/or Without Human Immunodeficiency Virus (HIV) | CD8+ among HIV+ participants | 198 cells/µL |
| Grade 1 | Change in Immune Cytokines Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8) and Cluster of Differentiation 19 (CD19) Among Participants With and/or Without Human Immunodeficiency Virus (HIV) | CD8+/All participants | 104.5 cells/µL |
| Grade 1 | Change in Immune Cytokines Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8) and Cluster of Differentiation 19 (CD19) Among Participants With and/or Without Human Immunodeficiency Virus (HIV) | CD19+/All participants | -40 cells/µL |
| Grade 1 | Change in Immune Cytokines Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8) and Cluster of Differentiation 19 (CD19) Among Participants With and/or Without Human Immunodeficiency Virus (HIV) | CD4+ among HIV+ participants | 72 cells/µL |
| Grade 2 | Change in Immune Cytokines Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8) and Cluster of Differentiation 19 (CD19) Among Participants With and/or Without Human Immunodeficiency Virus (HIV) | CD8+ among HIV+ participants | 129 cells/µL |
| Grade 2 | Change in Immune Cytokines Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8) and Cluster of Differentiation 19 (CD19) Among Participants With and/or Without Human Immunodeficiency Virus (HIV) | CD4+/All participants | 37 cells/µL |
| Grade 2 | Change in Immune Cytokines Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8) and Cluster of Differentiation 19 (CD19) Among Participants With and/or Without Human Immunodeficiency Virus (HIV) | CD4+ among HIV+ participants | 37 cells/µL |
| Grade 2 | Change in Immune Cytokines Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8) and Cluster of Differentiation 19 (CD19) Among Participants With and/or Without Human Immunodeficiency Virus (HIV) | CD8+/All participants | 115 cells/µL |
| Grade 2 | Change in Immune Cytokines Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8) and Cluster of Differentiation 19 (CD19) Among Participants With and/or Without Human Immunodeficiency Virus (HIV) | CD19+/All participants | -55 cells/µL |
| Grade 3 | Change in Immune Cytokines Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8) and Cluster of Differentiation 19 (CD19) Among Participants With and/or Without Human Immunodeficiency Virus (HIV) | CD4+ among HIV+ participants | -14 cells/µL |
| Grade 3 | Change in Immune Cytokines Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8) and Cluster of Differentiation 19 (CD19) Among Participants With and/or Without Human Immunodeficiency Virus (HIV) | CD8+ among HIV+ participants | 75 cells/µL |
| Grade 3 | Change in Immune Cytokines Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8) and Cluster of Differentiation 19 (CD19) Among Participants With and/or Without Human Immunodeficiency Virus (HIV) | CD4+/All participants | -54 cells/µL |
| Grade 3 | Change in Immune Cytokines Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8) and Cluster of Differentiation 19 (CD19) Among Participants With and/or Without Human Immunodeficiency Virus (HIV) | CD19+/All participants | -75 cells/µL |
| Grade 3 | Change in Immune Cytokines Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8) and Cluster of Differentiation 19 (CD19) Among Participants With and/or Without Human Immunodeficiency Virus (HIV) | CD8+/All participants | 73 cells/µL |
p-value: 0.07Wilcoxon signed rank test
p-value: 0.13Wilcoxon signed rank test
p-value: 0.15Wilcoxon signed rank test
p-value: 0.03Wilcoxon signed rank test
p-value: 0.06Wilcoxon signed rank test
p-value: 0.79Wilcoxon rank sum test
p-value: 0.03Wilcoxon signed rank test
p-value: 0.008Wilcoxon signed rank test
p-value: 0.12Wilcoxon signed rank test
p-value: 0.02Wilcoxon signed rank test
p-value: 0.02Wilcoxon signed rank test
p-value: 0.36Wilcoxon signed rank test
p-value: 0.002Wilcoxon signed rank test
p-value: 0.0002Wilcoxon signed rank test
p-value: <0.0001Wilcoxon signed rank test
Secondary
Human Immunodeficiency Virus (HIV) Viral Load
HIV viral load in peripheral blood mononuclear cells was assessed by quantitative real-time polymerase chain reaction (PCR). The lower limit of detection for HIV viral load is \<50 copies mL.
Time frame: Baseline to 4 weeks, baseline to 8 weeks and baseline to end of treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Grade 1 | Human Immunodeficiency Virus (HIV) Viral Load | 0 Copies/mL |
| Grade 2 | Human Immunodeficiency Virus (HIV) Viral Load | 0 Copies/mL |
| Grade 3 | Human Immunodeficiency Virus (HIV) Viral Load | 0 Copies/mL |
p-value: 0.56Wilcoxon signed rank test
p-value: 0.65Wilcoxon signed rank test
p-value: 0.56Wilcoxon signed rank test
Secondary
Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions
The number of participants responding to each question with the indicated responses is shown. Changes in quality of life in participants receiving pomalidomide. HRQL was analyzed using a mixed-model repeated-measures analysis and the marginal homogeneity test for Kaposi sarcoma-specific questions. Three supplemental questions addressing pain, swelling, and satisfaction with physical appearance was used to collect quality of life data.
Time frame: Baseline, timepoint 1: after 3 months of therapy, and timepoint 2: 1 month after completion of therapy
Population: 22 participants were analyzed at baseline. 19/22 participants were evaluable and analyzed at timepoint 2 and timepoint 3 because the QOL data was not collected on the other three participants at those timepoints. Baseline n=22, timepoint 2 = 19, and timepoint 3 = 19. \*Sum of two preceding columns. ϮSum of three preceding columns.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Grade 1 | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance at baseline | 6 Participants |
| Grade 1 | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs at baseline | 6 Participants |
| Grade 1 | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities timepoint 3:1month after completion of therapy | 7 Participants |
| Grade 1 | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance - timepoint 2: after 3 months of therapy | 6 Participants |
| Grade 1 | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs - timepoint 2: after 3 months of therapy | 7 Participants |
| Grade 1 | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance - timepoint 3: 1 month after completion of therapy | 3 Participants |
| Grade 1 | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs - timepoint 3: 1 month after completion of therapy | 6 Participants |
| Grade 1 | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities - timepoint 2: after 3 months of therapy | 7 Participants |
| Grade 1 | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities at baseline | 10 Participants |
| Grade 2 | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance - timepoint 3: 1 month after completion of therapy | 2 Participants |
| Grade 2 | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance - timepoint 2: after 3 months of therapy | 1 Participants |
| Grade 2 | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs - timepoint 3: 1 month after completion of therapy | 3 Participants |
| Grade 2 | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities - timepoint 2: after 3 months of therapy | 5 Participants |
| Grade 2 | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs - timepoint 2: after 3 months of therapy | 2 Participants |
| Grade 2 | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities timepoint 3:1month after completion of therapy | 5 Participants |
| Grade 2 | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities at baseline | 3 Participants |
| Grade 2 | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs at baseline | 2 Participants |
| Grade 2 | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance at baseline | 6 Participants |
| Grade 3 | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs at baseline | 8 Participants |
| Grade 3 | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance - timepoint 2: after 3 months of therapy | 7 Participants |
| Grade 3 | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities at baseline | 13 Participants |
| Grade 3 | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities - timepoint 2: after 3 months of therapy | 12 Participants |
| Grade 3 | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance - timepoint 3: 1 month after completion of therapy | 5 Participants |
| Grade 3 | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs - timepoint 2: after 3 months of therapy | 9 Participants |
| Grade 3 | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance at baseline | 12 Participants |
| Grade 3 | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities timepoint 3:1month after completion of therapy | 12 Participants |
| Grade 3 | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs - timepoint 3: 1 month after completion of therapy | 9 Participants |
| Grade 4 | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance - timepoint 3: 1 month after completion of therapy | 5 Participants |
| Grade 4 | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities at baseline | 2 Participants |
| Grade 4 | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities - timepoint 2: after 3 months of therapy | 5 Participants |
| Grade 4 | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities timepoint 3:1month after completion of therapy | 4 Participants |
| Grade 4 | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance at baseline | 6 Participants |
| Grade 4 | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance - timepoint 2: after 3 months of therapy | 5 Participants |
| Grade 4 | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs at baseline | 5 Participants |
| Grade 4 | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs - timepoint 2: after 3 months of therapy | 4 Participants |
| Grade 4 | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs - timepoint 3: 1 month after completion of therapy | 4 Participants |
| Quite a Bit | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs - timepoint 2: after 3 months of therapy | 4 Participants |
| Quite a Bit | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance at baseline | 3 Participants |
| Quite a Bit | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities at baseline | 5 Participants |
| Quite a Bit | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities timepoint 3:1month after completion of therapy | 1 Participants |
| Quite a Bit | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance - timepoint 2: after 3 months of therapy | 5 Participants |
| Quite a Bit | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs - timepoint 3: 1 month after completion of therapy | 5 Participants |
| Quite a Bit | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs at baseline | 4 Participants |
| Quite a Bit | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance - timepoint 3: 1 month after completion of therapy | 8 Participants |
| Quite a Bit | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities - timepoint 2: after 3 months of therapy | 1 Participants |
| Very Much | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities - timepoint 2: after 3 months of therapy | 1 Participants |
| Very Much | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance at baseline | 1 Participants |
| Very Much | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs - timepoint 2: after 3 months of therapy | 2 Participants |
| Very Much | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities at baseline | 2 Participants |
| Very Much | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs at baseline | 5 Participants |
| Very Much | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities timepoint 3:1month after completion of therapy | 2 Participants |
| Very Much | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance - timepoint 2: after 3 months of therapy | 2 Participants |
| Very Much | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs - timepoint 3: 1 month after completion of therapy | 1 Participants |
| Very Much | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance - timepoint 3: 1 month after completion of therapy | 1 Participants |
| Somewhat or MoreϮ | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities - timepoint 2: after 3 months of therapy | 7 Participants |
| Somewhat or MoreϮ | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance - timepoint 3: 1 month after completion of therapy | 14 Participants |
| Somewhat or MoreϮ | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities timepoint 3:1month after completion of therapy | 7 Participants |
| Somewhat or MoreϮ | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs at baseline | 14 Participants |
| Somewhat or MoreϮ | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance at baseline | 10 Participants |
| Somewhat or MoreϮ | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs - timepoint 2: after 3 months of therapy | 10 Participants |
| Somewhat or MoreϮ | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities at baseline | 9 Participants |
| Somewhat or MoreϮ | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs - timepoint 3: 1 month after completion of therapy | 10 Participants |
| Somewhat or MoreϮ | Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance - timepoint 2: after 3 months of therapy | 12 Participants |
Secondary
Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions
The percentage of participants responding to each question with the indicated responses is shown. Changes in quality of life in participants receiving pomalidomide. HRQL was analyzed using a mixed-model repeated-measures analysis and the marginal homogeneity test for Kaposi sarcoma-specific questions. Three supplemental questions addressing pain, swelling, and satisfaction with physical appearance was used to collect quality of life data.
Time frame: Baseline, timepoint 1: after 3 months of therapy, and timepoint 2: 1 month after completion of therapy
Population: 22 participants were analyzed at baseline. 19/22 participants were evaluable and analyzed at timepoint 2 and timepoint 3 because the QOL data was not collected on the other 3 participants at those timepoints. Baseline n=22, timepoint 2 = 19, and timepoint 3 = 19. \*Sum of two preceding columns. ϮSum of three preceding columns.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Grade 1 | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance at baseline | 27.3 percentage of participants |
| Grade 1 | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs at baseline | 27.3 percentage of participants |
| Grade 1 | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities timepoint 3:1month after completion of therapy | 36.8 percentage of participants |
| Grade 1 | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance - timepoint 2: after 3 months of therapy | 31.6 percentage of participants |
| Grade 1 | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs - timepoint 2: after 3 months of therapy | 36.8 percentage of participants |
| Grade 1 | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance - timepoint 3: 1 month after completion of therapy | 15.8 percentage of participants |
| Grade 1 | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs - timepoint 3: 1 month after completion of therapy | 31.6 percentage of participants |
| Grade 1 | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities - timepoint 2: after 3 months of therapy | 36.8 percentage of participants |
| Grade 1 | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities at baseline | 45.5 percentage of participants |
| Grade 2 | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance - timepoint 3: 1 month after completion of therapy | 10.5 percentage of participants |
| Grade 2 | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance - timepoint 2: after 3 months of therapy | 4.5 percentage of participants |
| Grade 2 | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs - timepoint 3: 1 month after completion of therapy | 15.8 percentage of participants |
| Grade 2 | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities - timepoint 2: after 3 months of therapy | 26.3 percentage of participants |
| Grade 2 | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs - timepoint 2: after 3 months of therapy | 10.5 percentage of participants |
| Grade 2 | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities timepoint 3:1month after completion of therapy | 26.3 percentage of participants |
| Grade 2 | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities at baseline | 13.6 percentage of participants |
| Grade 2 | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs at baseline | 9.1 percentage of participants |
| Grade 2 | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance at baseline | 27.3 percentage of participants |
| Grade 3 | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs at baseline | 36 percentage of participants |
| Grade 3 | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance - timepoint 2: after 3 months of therapy | 36.8 percentage of participants |
| Grade 3 | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities at baseline | 59.1 percentage of participants |
| Grade 3 | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities - timepoint 2: after 3 months of therapy | 63.2 percentage of participants |
| Grade 3 | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance - timepoint 3: 1 month after completion of therapy | 26.3 percentage of participants |
| Grade 3 | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs - timepoint 2: after 3 months of therapy | 47 percentage of participants |
| Grade 3 | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance at baseline | 54.6 percentage of participants |
| Grade 3 | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities timepoint 3:1month after completion of therapy | 63.2 percentage of participants |
| Grade 3 | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs - timepoint 3: 1 month after completion of therapy | 47 percentage of participants |
| Grade 4 | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance - timepoint 3: 1 month after completion of therapy | 26.3 percentage of participants |
| Grade 4 | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities at baseline | 9.1 percentage of participants |
| Grade 4 | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities - timepoint 2: after 3 months of therapy | 26.3 percentage of participants |
| Grade 4 | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities timepoint 3:1month after completion of therapy | 21.1 percentage of participants |
| Grade 4 | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance at baseline | 27.3 percentage of participants |
| Grade 4 | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance - timepoint 2: after 3 months of therapy | 26.3 percentage of participants |
| Grade 4 | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs at baseline | 22.7 percentage of participants |
| Grade 4 | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs - timepoint 2: after 3 months of therapy | 21.1 percentage of participants |
| Grade 4 | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs - timepoint 3: 1 month after completion of therapy | 21.1 percentage of participants |
| Quite a Bit | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs - timepoint 2: after 3 months of therapy | 21.1 percentage of participants |
| Quite a Bit | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance at baseline | 13.6 percentage of participants |
| Quite a Bit | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities at baseline | 22.7 percentage of participants |
| Quite a Bit | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities timepoint 3:1month after completion of therapy | 5.3 percentage of participants |
| Quite a Bit | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance - timepoint 2: after 3 months of therapy | 26.3 percentage of participants |
| Quite a Bit | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs - timepoint 3: 1 month after completion of therapy | 26.3 percentage of participants |
| Quite a Bit | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs at baseline | 18.2 percentage of participants |
| Quite a Bit | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance - timepoint 3: 1 month after completion of therapy | 42.1 percentage of participants |
| Quite a Bit | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities - timepoint 2: after 3 months of therapy | 5.3 percentage of participants |
| Very Much | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities - timepoint 2: after 3 months of therapy | 5.3 percentage of participants |
| Very Much | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance at baseline | 4.5 percentage of participants |
| Very Much | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs - timepoint 2: after 3 months of therapy | 10.5 percentage of participants |
| Very Much | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities at baseline | 9.1 percentage of participants |
| Very Much | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs at baseline | 22.7 percentage of participants |
| Very Much | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities timepoint 3:1month after completion of therapy | 10.5 percentage of participants |
| Very Much | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance - timepoint 2: after 3 months of therapy | 10.5 percentage of participants |
| Very Much | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs - timepoint 3: 1 month after completion of therapy | 5.3 percentage of participants |
| Very Much | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance - timepoint 3: 1 month after completion of therapy | 5.3 percentage of participants |
| Somewhat or MoreϮ | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities - timepoint 2: after 3 months of therapy | 36.8 percentage of participants |
| Somewhat or MoreϮ | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance - timepoint 3: 1 month after completion of therapy | 73.7 percentage of participants |
| Somewhat or MoreϮ | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities timepoint 3:1month after completion of therapy | 36.8 percentage of participants |
| Somewhat or MoreϮ | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs at baseline | 63.6 percentage of participants |
| Somewhat or MoreϮ | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance at baseline | 45.4 percentage of participants |
| Somewhat or MoreϮ | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs - timepoint 2: after 3 months of therapy | 52.6 percentage of participants |
| Somewhat or MoreϮ | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | Pain has interfered with my normal work or activities at baseline | 40.9 percentage of participants |
| Somewhat or MoreϮ | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I have had swelling in my face, arms, or legs - timepoint 3: 1 month after completion of therapy | 52.6 percentage of participants |
| Somewhat or MoreϮ | Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions | I am satisfied with my physical appearance - timepoint 2: after 3 months of therapy | 63.2 percentage of participants |
Secondary
Self-Reported Health-Related Quality of Life (HRQL) Instrument: Functional Assessment of Human Immunodeficiency Virus Infection (FAHI)
Changes in quality of life in participants receiving pomalidomide. HRQL was analyzed using a mixed-model repeated-measures analysis for FAHI and the marginal homogeneity test for Kaposi sarcoma-specific questions such as physical well-being (PWB), emotional well-being (EWB), functional and global well-being (FGWB), social well-being (SWB), and cognitive functioning (CF). The range of possible scores for each subscale was as follows: PWB and EWB, 0 to 40; FGWB, 0 to 52; SWB, 0 to 32; CF, 0 to 12. The total FAHI score, with possible scores ranging from 0 to 176, was calculated as the sum of all five subscale values, with higher scores indicating better results. Questionnaires completed at early withdrawal visits were not included in the analyses.
Time frame: Baseline, after 3 months of therapy, and after completion of therapy, up to 48 weeks
Population: Missing responses within questionnaire in category FAHI Total at baseline (n=21). And missing responses within questionnaire in category FAHI Total after completion of therapy (n=17).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Grade 1 | Self-Reported Health-Related Quality of Life (HRQL) Instrument: Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) | FAHI Total | 123.0 score on a scale | Standard Deviation 30.2 |
| Grade 1 | Self-Reported Health-Related Quality of Life (HRQL) Instrument: Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) | Physical well-being | 30.8 score on a scale | Standard Deviation 8.7 |
| Grade 1 | Self-Reported Health-Related Quality of Life (HRQL) Instrument: Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) | Emotional well-being | 25.1 score on a scale | Standard Deviation 7.6 |
| Grade 1 | Self-Reported Health-Related Quality of Life (HRQL) Instrument: Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) | Functional and global well-being | 34.4 score on a scale | Standard Deviation 10.3 |
| Grade 1 | Self-Reported Health-Related Quality of Life (HRQL) Instrument: Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) | Social well-being | 22.1 score on a scale | Standard Deviation 6.6 |
| Grade 1 | Self-Reported Health-Related Quality of Life (HRQL) Instrument: Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) | Cognitive functioning | 9.1 score on a scale | Standard Deviation 2.7 |
| Grade 2 | Self-Reported Health-Related Quality of Life (HRQL) Instrument: Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) | Cognitive functioning | 8.5 score on a scale | Standard Deviation 2.7 |
| Grade 2 | Self-Reported Health-Related Quality of Life (HRQL) Instrument: Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) | FAHI Total | 123.4 score on a scale | Standard Deviation 28.4 |
| Grade 2 | Self-Reported Health-Related Quality of Life (HRQL) Instrument: Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) | Functional and global well-being | 34.5 score on a scale | Standard Deviation 10.1 |
| Grade 2 | Self-Reported Health-Related Quality of Life (HRQL) Instrument: Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) | Social well-being | 21.5 score on a scale | Standard Deviation 7.8 |
| Grade 2 | Self-Reported Health-Related Quality of Life (HRQL) Instrument: Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) | Physical well-being | 31.3 score on a scale | Standard Deviation 8.2 |
| Grade 2 | Self-Reported Health-Related Quality of Life (HRQL) Instrument: Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) | Emotional well-being | 27.7 score on a scale | Standard Deviation 7.5 |
| Grade 3 | Self-Reported Health-Related Quality of Life (HRQL) Instrument: Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) | Physical well-being | 31.3 score on a scale | Standard Deviation 9.1 |
| Grade 3 | Self-Reported Health-Related Quality of Life (HRQL) Instrument: Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) | Emotional well-being | 26.2 score on a scale | Standard Deviation 7.7 |
| Grade 3 | Self-Reported Health-Related Quality of Life (HRQL) Instrument: Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) | Cognitive functioning | 8.7 score on a scale | Standard Deviation 2.3 |
| Grade 3 | Self-Reported Health-Related Quality of Life (HRQL) Instrument: Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) | Functional and global well-being | 32.9 score on a scale | Standard Deviation 9.6 |
| Grade 3 | Self-Reported Health-Related Quality of Life (HRQL) Instrument: Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) | FAHI Total | 118. score on a scale | Standard Deviation 29 |
| Grade 3 | Self-Reported Health-Related Quality of Life (HRQL) Instrument: Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) | Social well-being | 20.9 score on a scale | Standard Deviation 6.8 |
Other Pre-specified
Number of Dose-limiting Toxicities
A dose limiting toxicity is any grade 4 toxicity not including lymphopenia, cluster of differentiation 4 (CD4) lymphopenia, neutropenia, anemia and bilirubin or creatine kinase (CK) elevation that is at least possibly due to pomalidomide and is not attributable to human immunodeficiency virus (HIV), its therapy or Kaposi Sarcoma (KS). Any grade 3 toxicity that is at least possibly due to pomalidomide and is not attributable to HIV, its therapy, or KS and restrictions such as grade 3 thrombocytopenia if grade 3 for 14 days or more, Grade 3 asymptomatic hyperuricemia or hypophosphatemia, or Grade 3 amylase elevations. Any arterial or deep venous thromboembolic event or a second superficial thromboembolic event that is at least possibly due to pomalidomide. Inability to deliver pomalidomide on at least 50% of scheduled days during the first two cycles of therapy as a result of toxicity that is probably or definitely attributable to pomalidomide.
Time frame: First 8 weeks (2 cycles) of drug administration
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Grade 1 | Number of Dose-limiting Toxicities | 0 toxicities |
Other Pre-specified
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time frame: Date treatment consent signed to date off study, approximately 124 months and 1 day.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Grade 1 | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | 28 Participants |